Detecting cancers Earlier Through Elective plasma-based CancerSEEK Testing – Ascertaining Serial Cancer patients to Enable New Diagnostic II (DETECT-ASCEND2) - DETECT-ASCEND 2

Exact Sciences Thrive LLC0 sites106 target enrollmentAugust 9, 2023

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: breast cancer, lung cancer, colorectal cancer, prostate cancer, bladder cancer, uterine cancer, kidney/renal pelvis cancer, pancreatic cancer, liver cancer, stomach cancer, ovarian cancer, esophageal cancer, head and neck squamous cell cancer, thyroid cancer, small intestine cancer, cervical cancer, anal cancer, vulva cancer, testicular cancer
Sponsor: Exact Sciences Thrive LLC
Enrollment: 106
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

August 9, 2023

End Date

December 20, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Exact Sciences Thrive LLC

•All Subjects
•1\. \=50 years of age
•2\. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator
•Cancer Subjects Only
•3\.Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data.
•4\. Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

•1\. Prior or concurrent cancer diagnosis defined as:
•a. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
•b. Recurrence of the same primary cancer within any timeframe; OR c. Concurrent diagnosis of multiple primary cancers
•2\. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
•3\. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo\-adjuvant chemotherapy, neo\-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
•4\. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
•5\. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
•6\. IV contrast (e.g., CT and MRI) within 1 day \[or 24 hours] prior to blood collection.
•7\. Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
•8\. Participant has an active febrile infection prior to blood draw.